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Biotechs say FDA regulations impede job creation

Friday, April 22, 2011 12:13 PM

Drug and medical device companies are having a hard time creating jobs and delivering innovative new therapies to patients because of tight government regulations, limits in science and research funding and high taxes reported biotech industry leaders at a recent congressional hearing in San Diego, according to The San Diego Union-Tribune.

The criticism was directed mostly toward the FDA.  Prescription drug approvals have dropped: last year, only 21 new drugs were FDA approved compared to 36 in 2004.

“There are whole areas (of drug development) that venture capitalists won’t pursue because the regulatory barriers are too high,” said David Gollaher, president and chief executive of the California Healthcare Institute in La Jolla.

California U.S. Representative Darrell Issa stated: “We were shocked to find out that the FDA is often one of the greatest impediments to job creation.”

FDA critics say the problem is in the increasing amount of time it takes the agency to process new product applications.

Since 2007, drug review times by the FDA have increased by 28%, while evaluations of devices have taken as much as 75% more time, Gollaher said.

They also point to a recent string of unexpected new drug rejections by the agency that forced developers to perform new tests on their experimental medications.

However, some argue the changes are good. Public Citizen and other consumer advocacy groups have commended the FDA for scrutinizing new medical products and requiring more safety testing before putting them on the market, reports The San Diego Union-Tribune.

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